Cephalalgia ( IF 4.9 ) Pub Date : 2021-05-13 , DOI: 10.1177/03331024211010305 Richard B Lipton 1, 2 , Rami Burstein 3 , Dawn C Buse 1 , David W Dodick 4 , Reija Koukakis 5 , Jan Klatt 6 , Sunfa Cheng 7 , Denise E Chou 7
Background
Ictal cutaneous allodynia, common in chronic migraine, is associated with reduced responses to acute treatment with triptans. Allodynia’s impact on the efficacy of newer preventive treatments such as erenumab is unknown.
Methods
Post-hoc subgroup analysis of a double-blind, randomized, placebo-controlled 12-week study of erenumab in chronic migraine, contrasting those with no allodynia with those with moderate-severe allodynia assessed with the Allodynia Symptom Checklist-12, was undertaken.
Results
Of 648 randomized individuals with baseline Allodynia Symptom Checklist-12 scores, 386 (59.6%) had no allodynia and 153 (23.6%) had moderate-to-severe allodynia. Mean (standard deviation) baseline monthly migraine days were 17.6 (4.8) and 18.9 (4.3), respectively. Compared to placebo, the erenumab group had greater reductions in monthly migraine days and monthly acute migraine-specific medication days in both no allodynia and allodynia subgroups. Mean (95% confidence interval) treatment differences in change from baseline for monthly migraine days at week 12 were −2.5 (−3.7, −1.4) in the no allodynia subgroup and −3.3 (−5.3, −1.3) in the moderate-severe allodynia subgroup. Change in acute migraine-specific medication days were −3.3 (−4.3, −2.3) and −2.5 (−4.3, −0.8), respectively.
Conclusions
Erenumab’s efficacy in reducing monthly migraine days and acute migraine-specific medication days in chronic migraine was not impacted by the presence of moderate-severe ictal allodynia.
Trial registration: ClinicalTrials.gov NCT02066415
中文翻译:
erenumab 在伴有和不伴有发作性异常性疼痛的慢性偏头痛患者中的疗效
背景
慢性偏头痛中常见的发作性皮肤异常性疼痛与对曲坦类药物急性治疗的反应降低有关。异常性疼痛对新的预防性治疗(如erenumab)疗效的影响尚不清楚。
方法
对 erenumab 治疗慢性偏头痛的一项双盲、随机、安慰剂对照的 12 周研究进行了事后亚组分析,将无异常性疼痛的患者与使用异常性疼痛症状检查表 12 评估的中重度异常性疼痛患者进行了对比。
结果
在 648 名具有基线异常性疼痛症状检查表 12 评分的随机个体中,386 人(59.6%)没有异常性疼痛,153 人(23.6%)有中度至重度异常性疼痛。平均(标准差)基线每月偏头痛天数分别为 17.6(4.8)和 18.9(4.3)。与安慰剂相比,erenumab 组在无异常性疼痛和异常性疼痛亚组中每月偏头痛天数和每月急性偏头痛特异性药物治疗天数的减少幅度更大。第 12 周每月偏头痛天数与基线变化的平均(95% 置信区间)治疗差异在无异常性疼痛亚组中为 -2.5(-3.7,-1.4),在中重度亚组中为 -3.3(-5.3,-1.3)异常性疼痛亚组。急性偏头痛特异性用药天数的变化分别为-3.3(-4.3,-2.3)和-2.5(-4.3,-0.8)。
结论
Erenumab 在减少慢性偏头痛中每月偏头痛天数和急性偏头痛特异性用药天数方面的疗效不受中重度发作期异常性疼痛的影响。
试验注册:ClinicalTrials.gov NCT02066415